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PubMed2003

Strategic Research Institute--first international siRNA conference. Prospect for new therapeutics and commercial opportunities for pharma and biotech. 24-25 March 2003, LaJolla, CA, USA.

Small interfering RNAs (siRNAs), with their power to selectively silence genes, have gained much attention from biotech and pharmaceutical companies and investors. Key players in the field, from innovative biotech start-ups to big pharmaceutical companies, gathered at Strategic Research Institute's First International siRNA conference in the scenic Hilton La Jolla Torrey Pines. Topics addressed ranged from the latest technology advances and applications of RNA interference (RNAi) in drug discovery, to critical business issues such as intellectual property portfolio strategy and market prospects. While RNAi is indisputably accepted as a powerful tool in target validation and functional genomics, the concept of an siRNA drug is still viewed by big pharma companies as next-generation therapeutics. Yet challenges seem tractable. Several companies, such as Ribozyme Pharmaceuticals Inc, Alnylam Pharmaceuticals and Intradigm Corp, are working hard to prove that the bigger companies are being too conservative. The conference provided a clear vision of RNAi in drug discovery today, its potential and remaining challenges.

Animals↗
PubMed2003

The great transition.

As China's economy grows and opens further, the opportunity it presents to multinationals is changing. Foreign companies are moving to country development and new strategic choices. Now, foreign firms can actually go after the Chinese domestic market, and it's worth going after. Improvements in China's infrastructure, workforce, and regulatory environment are making it possible for companies to lower their costs to reap new competitive advantages. Multifaceted and often-shifting risks accompany this shifting opportunity. The reforms required for admission into the WTO will be politically difficult for China to implement, and its progress will be slowed by the scarcity of resources for the country's shaky banking system, the inadequacy of the social safety net, environmental problems, and local governments' cash shortage. China's breathtaking 9% average annual GDP growth rests on an unsteady foundation of overcapitalized state-owned enterprises, which have oversupplied many markets, and fiercely protectionist regional government officials pursuing growth-at-almost-all-costs policies. Frequent changes in regulations, bureaucracies, and reporting relationships will continue to make planning difficult, and, as the SARS epidemic demonstrated, there is always the potential for serious disruptions. But for at least the next ten years, multinationals should be the biggest winners in China. To reap the benefits, a multinational must properly nest its effort into its overall organization, show "one face to China" at the national level but also tailor local strategies, be wary of joint ventures, and mitigate risk, in particular the theft of intellectual property. China is a major opportunity for companies that forthrightly face its complexities. It will remain largely inscrutable--and unprofitable--for the rest.

China↗
PubMedDate not supplied

[Research and development. The value of patents].

The goal of innovative basic applied research is the award of patents for products and processes. Patents protect the exclusive use of these products and processes. Because of the high cost of research, it is important for governments to stimulate the creativity of researchers and provide economic incentives for them to develop patentable intellectual property. In the United States, an exchange program exists between the academic researchers and industry. This easy exchange of ideas is not adequately supported in Europe, especially in Italy. To further hinder researchers, the European Union has not yet passed legislation on patents.

Patents as Topic↗
PubMedDate not supplied

The role of the independent clinical laboratory in new assay development and commercialization.

Most would agree that these are exciting times in the field of laboratory medicine. As the body of scientific knowledge expands and research activities, such as those catalyzed by the sequencing of the human genome, bring us closer to the promise of personalized medicine, the clinical laboratory industry will have increasing opportunities to partner with owners of intellectual property to develop and commercialize new diagnostic tests. The large, independent clinical laboratories are particularly well positioned to commercialize important new tests, with their broad market penetration, infrastructure, and the scale to run esoteric tests cost-effectively.

Biological Assay↗
PubMed2003

Creating a virtual community of learning predicated on medical student learning styles.

UNLABELLED: To create a virtual community of learning within the Indiana University School of Medicine, learning tools were developed within ANGEL to meet the learning needs and habits of the medical students. METHODS: Determined by student feedback, the integration of digital audio recordings of class lectures into the course management content with several possible outputs was paramount. The other components included electronic enhancement of old exams and providing case-based tutorials within the ANGEL framework. RESULTS: Students are using the curriculum management system more. Faculty feel more secure about their intellectual property because of the authentication and security offered through the ANGEL system. The technology applications were comparatively easy to create and manage. The return on investment, particularly for the digital audio recording component, has been substantial. CONCLUSION: By considering student learning styles, extant curriculum management systems can be enhanced to facilitate student learning within an electronic environment.

Audiovisual Aids↗
PubMed2002

WTO: US and Argentina settle dispute over patents and data protection.

In May 2000, supplementing an earlier complaint filed in May 1999, the US filed a complaint against Argentina, alleging that its patent laws violate the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property (the TRIPS Agreement). The gist of the US complaint was that Argentina's law failed to provide: (1) adequate protection against "unfair" commercial use of undisclosed test data submitted in order to get market approval of pharmaceutical products; (2) certain safeguards for compulsory licences on an invention granted on the basis of inadequate working by the patent holder; and (3) adequate measures to prevent infringements of patent rights. The US also alleged that Argentina denies certain exclusive rights of patent holders, such as the exclusive right to import the patented product into the country. At the end of May 2002, the US and Argentina notified the WTO that they had reached a "mutually agreed solution," without prejudice to their respective rights and obligations under WTO agreements, and the US has withdrawn its complaint.

Argentina↗
PubMed2004

CAFTA will harm HIV care, according to critics. Final agreement helps drug companies, they say.

Negotiations on the Central American Free Trade Agreement will result in more deaths from AIDS in the Central American nations participating in the agreement, charge several organizations that work to provide health care to poor populations. The reason is that the United States pushed for new intellectual property rules that will obstruct access to medicine by increasing medicine prices and delaying or blocking generic competition, they contend.

Central America↗
PubMed2004

International pharmaceutical expenditure differentials: why?

The following questions facilitate further thought on the issue of reimportation: POLICY ISSUES: Who should pay for drug development? Do NCEs provide value for money invested? What is the most efficient means of developing new drugs? What is the proper balance between societal benefit and intellectual property protection? REGULATORY QUESTIONS: If reimportation or importation is permitted, how can the provenance of a product be protected? How is reimportation defined? Can a product be transported from the United States to Europe to Canada and then be sent back to the United States? Or, is reimportation a single-step process (e.g., United States to Canada and vice versa)? If reimportation is limited to Canada, can we expect that other countries would want to be included (or excluded) from our reimportation policy? Will state pharmacy practice acts be applicable to reimportation? Does reimportation alter the balance between state and federal regulations? If legal action occurs because of alleged harm from a reimported product, who is liable? MARKET ISSUES: Will U.S. prices rise in protected markets to compensate for losses due to reimports? Will Canadians be allowed to import prescription drugs from the United States?

Commerce↗
PubMed2004

Maori responsiveness in health and medical research: key issues for researchers (part 1).

INTRODUCTION: Application for contestable government-research funding and ethical approval requires researchers to outline how their intended research project contributes to Maori development or advancement. METHODS AND RESULTS: When formulating their research proposals, the key issues for researchers are research utility, defining Maori, informed consent, confidentiality, issues with human tissues and genetic material, participant remuneration and recognition (koha), intellectual property, and involvement of local Maori health or social services. CONCLUSIONS: The most common Maori responsiveness issues in research applications can be readily approached by researchers who address straightforward methodological concerns, by working through precedents established by peers and colleagues, as well as by working with end-users of their research.

Advisory Committees↗
PubMed2002

Phage Display Technologies - SMi Conference. 23-24 January 2002, London, UK.

This fairly small meeting, with about 50 attendees, covered all areas of antibody engineering from basic technologies to applications in both therapeutic and diagnostic areas. Despite the fact that nearly all speakers came from commercial organizations, the data presented were solid and highly informative. While new technologies, such as yeast or ribosome display, are integrating into the drug discovery process, vaccine technology looks like a promising alternative to human antibody therapy. New advances in the field, especially in technology, are primarily governed by the tight intellectual property situation.

Journal Article↗
PubMed2004

[Integrity in science: a constant concern].

Recently many academies, science foundations and university associations have placed scientific integrity high on the agenda. 'Scientific integrity' falls within the category internal ethical problems in science as opposed to the category external ethical problems (e.g. justification of the choice of the subject of research, independence of research, responsibility for possible applications) and differs from intrinsic ethical problems such as those generated by stemcell research, nuclear fusion, xenotransplantation a.o. Crucial for science is trust by colleagues and peers as well as the wider public. Trust is weakened by published cases of misconduct: fraud, deceit, and infringement of intellectual property. Scientific misconduct and fraud have been a worldwide phenomenon of all times. The borderline between acceptable and unacceptable conduct is often vague. Causes of scientific misconduct include pressure from powerful institutions, economic and financial motives, and own ambition and vanity of the scientists. Hard data on the occurrence of misconduct is lacking, but a present-day increase of misconduct is not inconceivable. Prevention of misconduct include corrective and antecipatory measures, but most important is the fostering of a scientific conscience and at a sense of proper values and standards.

Ethics, Research↗
PubMedDate not supplied

[Biotechnological invention patents: a legal-economic analysis].

Not without controversy, patents have traditionally been considered as elements which stimulate and protect inventive activity. In this article, we look at the economic advantages of a patent system and also at the possible critcisms. We then examine the application of patents in modern biotechnology. After concluding that current intellectual property laws do not come out clearly against the protection of biotechnology inventions, we then review the proposals for European Union regulation in the form of a directive which would clarify patenting possibilities.

Biotechnology↗
PubMed2003

Patent law--balancing profit maximization and public access to technology.

This article addresses the contemporary issue of balancing the need for patent protection for intellectual property with the resulting restriction of public access to new technology. The author argues that patent law protects private property rights rather than creating monopolies. Additionally, the author discusses how restricting access to patented technology, such as pharmaceuticals, can affect public health problems, such as the HIV/AIDS epidemic in developing nations. The author then concludes with some proposals for making patented technology available to people in developing nations who need access to such technology but who are unable to afford its high costs due to patent protection.

Anti-HIV Agents↗
PubMedDate not supplied

Patent protection for stem cell procedures under the law of the European Union.

Stem cell research shows an immense diagnostic and therapeutic potential. The procedures based on human stem cells seem to allow new medical treatments for serious diseases like Parkinson's or Alzheimer's disease, leukaemia or diabetes. However, as no company or inventor would take the risk of immense investments without an adequate legal protection of the possible benefits arising out of their work, intellectual property law plays a pivotal role for the further development of stem cell techniques. Although international patent law knows protection of inventions using biological substances and living matter for about 160 years, patents on stem cells, DNA and other parts of the human body raise specific objections. Nevertheless, from a strictly legal angle, there are no barriers to patents on stem cell procedures. In particular, Art. 6 of the "Directive 98/44/EC of the European Parliament and of the Council of the European Union of July 6, 1998 on the legal protection of biotechnological inventions" - which qualifies inventions as unpatentable where their commercial exploitation would be contrary to ordre public or morality - does not hinder patent protection for stem cell research.

Adult↗
PubMed2006

Costs and benefits of communicating product safety information to the public via the Internet.

Procter & Gamble (P&G) developed Science-in-the-Box (SIB; www.scienceinthebox.com) after discussions with their stakeholders as to how the consumer products company could better communicate key environmental performance and safety information to the public. A series of workshops enabled P&G to understand that consumers and other key business decision makers wanted meaningful information about the science behind P&G products. In addition, it was clear that making such information available would produce business benefits by encouraging long-term relationships with decision makers ranging from consumers and retailers to policy makers and nongovernmental organizations. These benefits were not necessarily quantifiable in the short term, but they still had to be balanced by the costs in terms of resource commitment and potential intellectual property issues. Since its inception in September 2002, SIB has successfully reached key target audiences and built improved credibility and confidence in P&G products and approaches. The website is now available in English, French, Spanish, German, and Italian and is used by consumers, journalists, teachers, scientists, and policy makers. Several user surveys carried out during the initial developmental period, together with unsolicited e-mail feedback, have demonstrated that SIB has successfully created a platform for continuous dialogue with consumers and other interested parties.

Communication↗
PubMed2006

Functional annotation and analysis of Korean patented biological sequences using bioinformatics.

A recent report of the Korean Intellectual Property Office (KIPO) showed that the number of biological sequence-based patents is rapidly increasing in Korea. We present biological features of Korean patented sequences though bioinformatic analysis. The analysis is divided into two steps. The first is an annotation step in which the patented sequences were annotated with the Reference Sequence (RefSeq) database. The second is an association step in which the patented sequences were linked to genes, diseases, pathway, and biological functions. We used Entrez Gene, Online Mendelian Inheritance in Man (OMIM), Kyoto Encyclopedia of Genes and Genomes (KEGG), and Gene Ontology (GO) databases. Through the association analysis, we found that nearly 2.6% of human genes were associated with Korean patenting, compared to 20% of human genes in the U.S. patent. The association between the biological functions and the patented sequences indicated that genes whose products act as hormones on defense responses in the extra-cellular environments were the most highly targeted for patenting. The analysis data are available at http://www.patome.net.

Base Sequence↗
PubMed2006

[Emphasizing the research for ocular drug delivery system].

Choosing appropriate drug delivery system can apparently improve drug efficacy, prolong action time and decrease adverse reaction. In recent years, with the progress of macromolecule chemistry, the research of ocular drug delivery system has been developed rapidly. The present article reviews the progress of ocular drug delivery system and its development in our country. This article also discusses how to exploit the macromolecule polymer material with independence intellectual property rights, and how to promote the studies of intraocular pharmacokinetics and ocular toxicology about new ocular drug delivery system.

Administration, Topical↗